NASDAQ OMX

Novavax Announces Positive Topline Data from Phase 2 Older Adult Trial and Provides Path Forward for RSV F Vaccine Programs

Dela
  • Phase 2 data in older adults (E205) demonstrate adjuvants and 2-dose regimens significantly increase the magnitude, duration and quality of the RSV F Vaccine immune response
     
  • New data demonstrate that Novavax' construct is a stable prefusogenic RSV F antigen, distinctive from other candidates, that elicits potent neutralizing antibody responses to multiple key epitopes 
     
  • Path forward for a Phase 2 efficacy trial in 2018 based on signal in COPD population identified in prior older adult clinical trials 
     
  • Phase 3 Prepare(TM) trial accelerating and now includes 80 sites across 11 countries allowing continuous enrollment across global seasons      

GAITHERSBURG, Md., July 24, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced positive topline data from its Phase 2 safety and immunogenicity trial of the RSV F Vaccine in older adults, new preclinical data on its RSV F Vaccine construct, additional findings from the prior Phase 2 and Phase 3 clinical trials in older adults (E201 and E301), and an operational update on the Phase 3 clinical trial of the RSV F Vaccine for infants via maternal immunization, known as Prepare(TM). The Company anticipates initiating a Phase 2 efficacy trial in older adults in 2018.

Topline data from the Phase 2 older adult safety and immunogenicity trial (E205) demonstrate the benefit of adjuvant formulations and two-dose regimens. The objective of the Phase 2 randomized, observer-blinded, placebo-controlled trial was to assess safety and immunogenicity of one and two-dose regimens of the RSV F Vaccine, with and without aluminum phosphate or Novavax' proprietary Matrix-M(TM) adjuvant, in 300 older adults.  Participants were enrolled and vaccinated outside of the RSV season to best assess immunogenicity of the treatment arms. Immunogenicity outcomes indicate both aluminum phosphate and Matrix-M adjuvants significantly increased the magnitude, duration and quality of the immune response relative to a control of 135 microgram dose of the RSV F antigen alone (the formulation used in the prior Phase 3 older adults efficacy study). Similarly, two-dose regimens significantly increased immune responses and suggests two doses of the RSV F Vaccine with adjuvant may augment durability of the immune response to the vaccine. The data strongly support the inclusion of adjuvanted formulations of the RSV F Vaccine in future older adult trials.  All formulations and regimens were safe and well-tolerated.

Recent scientific advances in protein structure imaging and immune measures have led to new insights about the structure and immune responses elicited by the Novavax RSV F antigen.  These new findings identify Novavax' vaccine construct as a stable prefusogenic RSV F protein nanoparticle.  In addition, new analyses have confirmed and expanded the data, demonstrating that the vaccine induces a repertoire of broadly neutralizing RSV F antibodies in humans that are more potent than palivizumab (Synagis®). These new structural and immunological analyses validate the RSV F Vaccine as a highly immunogenic antigen with the potential to provide protection against RSV disease.

Older adult Phase 3 trial data in a recent post-hoc analysis indicate the RSV F Vaccine was associated with a 61% reduction in hospitalizations due to chronic obstructive pulmonary disease (COPD) exacerbations. Review of the E201 database showed a similar signal supporting this finding. COPD exacerbations represent an unmet medical need and a significant healthcare cost burden. Novavax plans to initiate a Phase 2 efficacy trial in older adults in 2018, that will evaluate COPD exacerbations as a prospective endpoint.

Prepare, the Phase 3 trial of the RSV F Vaccine for infants via maternal immunization, conducted in collaboration with the Bill and Melinda Gates Foundation, continues its momentum into the third global season of enrollment. Prepare's global footprint has grown from 16 sites in five countries in its first global RSV season of enrollment to 80 sites in 11 countries. The clinical trial infrastructure and experience developed over the last two seasons establish the foundation to efficiently enroll and execute this first of its kind global maternal immunization clinical trial.

"Since September, we have worked to confirm that our RSV F Vaccine elicits a broadly neutralizing antibody response. Through our E205 trial, we have demonstrated adjuvant strategies that magnify and enrich the quality of that underlying antibody response. When combined with the COPD data seen in both E301 and E201, we believe protecting individuals from COPD exacerbation presents a very exciting path forward in older adults," said Gregory Glenn, M.D., President of R&D.

"The new data that further characterizes the RSV F Vaccine and the benefit of adjuvants, combined with the hospitalization data in the COPD population, places us in a strong position to partner our RSV program," said Stanley C. Erck, President and CEO.  "We also look forward to continued momentum in Prepare trial enrollment and to developing our plans for the next steps in our RSV older adult program over the next 12 months."

Conference Call and Webcast

Date:             Monday, July 24, 2017
Time:             4:30 p.m. U.S. Eastern Time (ET)
Dial-in number:              (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode:             54820069
Webcast:             www.novavax.com, "Investors"/ "Events"
               
Conference call and webcast replay:

 
Dates:             Starting at 7:30 p.m. ET, July 24, 2017, until 7:30 p.m. ET, October 24, 2017 
Dial-in number:             (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode:             54820069
Webcast:             www.novavax.com, "Investors"/ "Events", until October 24, 2017
               

About Prepare(TM)

Prepare is a global pivotal Phase 3 clinical trial of RSV F Vaccine candidate for the protection of infants via maternal immunization. The Prepare trial is a randomized, observer-blinded, placebo-controlled trial in healthy pregnant women.  Participants are being vaccinated at a number of global clinical sites in advance of each region's RSV season. Novavax previously announced it was awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to support development of this RSV F Vaccine, which includes Prepare, product licensing efforts and World Health Organization ("WHO") prequalification of our RSV F Vaccine.

About RSV

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the US, RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age. 2,3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.4,5 Currently, there is no approved RSV vaccine available.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.

_______________

1 Nair, H., et al., (2010) Lancet. 375:1545 - 1555
2 Hall, C.B. et al. (2013) Pediatrics; 132(2):E341-348
3 Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv 
4 Glezen, W.P. et al. (1986) Am J Dis Child; 140:543-546
5 Glenn, G.M. et al. (2016) JID; 213(3):411-12

Contact:         

Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor Relations
ir@novavax.com  
240-268-2000
               
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Russo Partners, LLC
David Schull
Maggie Beller
david.schull@russopartnersllc.com 
maggie.beller@russopartnersllc.com 
212-845-4271




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.

Senaste pressmeddelandena från NASDAQ OMX

XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer18.10.2017 16:53Pressmeddelande

AUSTIN, Texas, Oct. 18, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today enrollment of the first patient into a Phase I single arm study evaluating the maximum tolerated dose of Onivyde® (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. The patient has begun treatment at Cedars-Sinai Medical Center under the care of Dr. Andrew Hendifar, the Study's Principle Investigator, Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai. A total of 16 patients are expected to be enrolled in the study. Dr. Hendifar commented, "We are excited to enroll our first patient in this novel combinatorial therapy for the treatment of advanced pancreatic cancer and cachexia. This is the first attempt to add an anti-inflammatory therapy to standard chemotherapy in an effort to improve the performanc

Nasdaq and SGX Establish Collaborative Listings Agreement18.10.2017 15:42Pressmeddelande

NEW YORK and SINGAPORE, Oct. 18, 2017 (GLOBE NEWSWIRE) -- Nasdaq Inc. (Nasdaq:NDAQ) and Singapore Exchange (SGX) today announced the signing of a collaborative agreement in a move to leverage their strengths as two of the leading listings venues in the U.S. and Asia respectively. The new agreement seeks to enhance the channels available for companies to access capital market funding and enhance their corporate profile in both markets. As part of this agreement, Nasdaq and SGX -- who also share a successful, long-term market technology relationship -- are currently exploring the demand among corporates for a concurrent or sequential listing on both exchanges. Nasdaq and SGX are committed to supporting companies that are interested in pursuing this route. "The business landscape today is borderless," said Loh Boon Chye, CEO, SGX. "Fast-growing Asian companies looking to tap the capital markets can choose to list on SGX on Asian home ground, and embark on a listing on Nasdaq

Momentum Group acquires remaining 70 percent of Knut Sehlins Industrivaruhus in Örnsköldsvik18.10.2017 15:00Pressmeddelande

TOOLS Sweden (part of Momentum Group) has owned 30 percent of the shares in Knut Sehlins Industrivaruhus AB ("Sehlins") in Örnsköldsvik, Sweden since 2007. Today, TOOLS acquired the remaining 70 percent of the shares in Sehlins, which thus becomes a wholly owned subsidiary. Sehlins generates annual revenue of approximately MSEK 40 and has 14 employees. Sehlins is one of the leading industrial resellers in Örnsköldsvik, an attractive and important market with a number of successful industrial companies. The aim of the acquisition for TOOLS is to continue developing Sehlins as a wholly owned business with a focus on delivering optimal service for existing and potential customers in the local market. Sehlins has been part of TOOLS since the chain was formed in 2003. Closing takes place in October 2017. The acquisition is expected to have a marginal impact on Momentum Group's earnings per share during the current financial year. Stockholm, 18 October 2017

Momentum Group förvärvar resterande 70 procent av Knut Sehlins Industrivaruhus i Örnsköldsvik18.10.2017 15:00Pressmeddelande

TOOLS Sverige (inom Momentum Group-koncernen) är sedan 2007 delägare med 30 procent av aktierna i Knut Sehlins Industrivaruhus AB ("Sehlins") i Örnsköldsvik. TOOLS har idag förvärvat resterande 70 procent av aktierna i Sehlins, vilket härigenom blir ett helägt dotterbolag. Sehlins omsätter cirka 40 MSEK per år och har 14 anställda. Sehlins är en av de ledande industriåterförsäljarna i Örnsköldsvik, en intressant och viktig marknad med ett antal framgångsrika industriföretag. Syftet med TOOLS förvärv är att fortsätta utveckla Sehlins som en helägd verksamhet med fokus på att serva nuvarande och potentiella kunder på den lokala marknaden på bästa sätt. Sehlins har varit en del av TOOLS sedan starten av kedjan 2003. Tillträde sker i oktober 2017. Förvärvet bedöms ha en marginell påverkan på Momentum Groups resultat per aktie under innevarande räkenskapsår. Stockholm den 18 oktober 2017 Momentum Group AB (publ) För ytterligare inf

Colliers International Expands in Washington, D.C.18.10.2017 14:30Pressmeddelande

Acquisition of Beltway Real Estate Services Firm Strengthens Ongoing Commitment to the Region TORONTO and WASHINGTON, Oct.  18, 2017  (GLOBE NEWSWIRE) -- Leading global commercial real estate services firm Colliers International Group Inc. (NASDAQ:CIGI)(TSX:CIGI) announced today the acquisition of leading tenant representation advisory firm Serten Advisors. With its office in Tysons Corner, the firm serves global, national, and regional clients with a highly skilled and experienced team of professionals that have more than 100 years of combined experience. "This strategic acquisition positions Colliers to gain additional market share and win new business in the vibrant and competitive Suburban DC markets," said Marty Pupil, Colliers International President | U.S. Brokerage. "Adding Steve and Paul and the rest of their talented leadership team to our existing group of professionals in the region will further position Colliers as the commercial real estate services firm of

InSphero to Present Novel 3D Human Liver Fibrosis Model at Annual Liver Meeting® in Washington, DC18.10.2017 14:00Pressmeddelande

InSphero AG / InSphero to Present Novel 3D Human Liver Fibrosis Model at Annual Liver Meeting® in Washington, DC . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. New 3D InSight(TM) Human Liver Fibrosis Model represents a powerful tool for screening efficacy and safety of anti-fibrotic drugs in vitro. Schlieren, Switzerland, Oct. 18, 2017 (GLOBE NEWSWIRE) -- InSphero AG, the leading supplier of assay-ready 3D cell culture models for accelerating drug discovery and development, will present data characterizing and demonstrating the utility of its new 3D InSight(TM) Human Liver Fibrosis Model for screening efficacy of anti-fibrotic drugs.  The findings will be presented at oral and poster presentations this Friday at the annual meeting of the American Association for the Study of Liver Disease (AASLD) Conference in Washington, DC.  Anti-fibrotic therapi

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum